Trial Information

Inclusion Criteria:

- Patients with measurable disease with evidence of at least one uni-dimensionally
measurable tumor (> 1 cm) by CT or MRI scan according to RECIST (Response Evaluation
Criteria in Solid Tumors) that the tumor has not been initially treated with surgery
or radiation therapy.

- Patients who will start treatment with bevacizumab combined with or without cytotoxic
chemotherapy within 14 days from signing consent. Patients treated on an approved IRB
therapeutic protocol for recurrent ovarian cancer with bevacizumab are eligible.

- Patients of childbearing potential must have a negative serum pregnancy test prior to
the study entry and be practicing an effective form of contraception.

- Patients who are older than 21 years of age.

- Patients who are able to understand and sign informed consent.

Exclusion Criteria:

- Patients treated on an approved IRB therapeutic protocol with a blinded arm of
bevacizumab or placebo are not eligible (IRB 07-078 and IRB 05-138).

- Patients with cardiac pacemakers.

- Patients with certain prosthetic devices and implants who are not compatible with the
high magnetic field present in the DCE-MRI scanners.

- Patients who have experienced a prior adverse reaction to the gadolinium complex
contrast agent used in DCE-MRI imaging and who don't meet criteria for creatinine and
nephrogenic systemic sclerosis risk per guidelines of department of radiology.

- Patients prone to claustrophobia.

- Patients on dialysis.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Development of automated motion correction algorithms and new functional methods that permit use of DCE-MRI in primary or metastatic tumors of the ovaries.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

David Gultekin, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08-132

NCT ID:

NCT00946140

Start Date:

July 2009

Completion Date:

July 2014

Related Keywords:

Ovarian Cancer

Ovary

MRI

08-132

Ovarian Neoplasms

Name

Location

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